Evaluation of USP apparatus 3 for dissolution testing of immediate-release products

Tekijä Yu, Lawrence X., Wang, Jin T., Hussain, Ajaz S.
Julkaistu 2002

Batch-to-Batch Quality Consistency Evaluation of Botanical Drug Products Using Multivariate Statistical Analysis of the Chromatographic Fingerprint

Tekijä Xiong, Haoshu, Yu, Lawrence X., Qu, Haibin
Julkaistu 2013

Mechanistic Approaches to Predicting Oral Drug Absorption

Tekijä Huang, Weili, Lee, Sau Lawrence, Yu, Lawrence X.
Julkaistu 2009

Utility of Physiologically Based Absorption Modeling in Implementing Quality by Design in Drug Development

Tekijä Zhang, Xinyuan, Lionberger, Robert A., Davit, Barbara M., Yu, Lawrence X.
Julkaistu 2011

Dissolution Testing for Generic Drugs: An FDA Perspective

Tekijä Anand, Om, Yu, Lawrence X., Conner, Dale P., Davit, Barbara M.
Julkaistu 2011

Application of Quality by Design to the Process Development of Botanical Drug Products: A Case Study

Tekijä Zhang, Lei, Yan, Binjun, Gong, Xingchu, Yu, Lawrence X., Qu, Haibin
Julkaistu 2013

International Guidelines for Bioequivalence of Systemically Available Orally Administered Generic Drug Products: A Survey of Similarities and Differences

Tekijä Davit, Barbara, Braddy, April C., Conner, Dale P., Yu, Lawrence X.
Julkaistu 2013

Influence of drug release properties of conventional solid dosage forms on the systemic exposure of highly soluble drugs

Tekijä Yu, Lawrence X., Ellison, Christopher D., Conner, Dale P., Lesko, Larry J., Hussain, Ajaz S.
Julkaistu 2001

Quality by Design: Concepts for ANDAs

Tekijä Lionberger, Robert A., Lee, Sau Lawrence, Lee, LaiMing, Raw, Andre, Yu, Lawrence X.
Julkaistu 2008

A multiple biomarker assay for quality assessment of botanical drugs using a versatile microfluidic chip

Tekijä Li, Zhen-Hao, Ai, Ni, Yu, Lawrence X., Qian, Zhong-Zhi, Cheng, Yi-Yu
Julkaisussa Sci Rep (2017)

FDA’s new pharmaceutical quality initiative: Knowledge-aided assessment & structured applications

Tekijä Yu, Lawrence X., Raw, Andre, Wu, Larisa, Capacci-Daniel, Christina, Zhang, Ying, Rosencrance, Susan
Julkaisussa Int J Pharm X (2019)

Applications of Human Pharmacokinetic Prediction in First-in-Human Dose Estimation

Tekijä Zou, Peng, Yu, Yanke, Zheng, Nan, Yang, Yongsheng, Paholak, Hayley J., Yu, Lawrence X., Sun, Duxin
Julkaistu 2012

Evaluation of a Scaling Approach for the Bioequivalence of Highly Variable Drugs

Tekijä Haidar, Sam H., Makhlouf, Fairouz, Schuirmann, Donald J., Hyslop, Terry, Davit, Barbara, Conner, Dale, Yu, Lawrence X.
Julkaistu 2008

Evaluation of a Scaling Approach for the Bioequivalence of Highly Variable Drugs

Tekijä Haidar, Sam H., Makhlouf, Fairouz, Schuirmann, Donald J., Hyslop, Terry, Davit, Barbara, Conner, Dale, Yu, Lawrence X.
Julkaistu 2008

Near-infrared spectral imaging for quality assurance of pharmaceutical products: Analysis of tablets to assess powder blend homogeneity

Tekijä Lyon, Robbe C., Lester, David S., Lewis, E. Neil, Lee, Eunah, Yu, Lawrence X., Jefferson, Everett H., Hussain, Ajaz S.
Julkaistu 2015

In Vitro Considerations to Support Bioequivalence of Locally Acting Drugs in Dry Powder Inhalers for Lung Diseases

Tekijä Lee, Sau Lawrence, Adams, Wallace P., Li, Bing V., Conner, Dale P., Chowdhury, Badrul A., Yu, Lawrence X.
Julkaistu 2009

Understanding Pharmaceutical Quality by Design

Tekijä Yu, Lawrence X., Amidon, Gregory, Khan, Mansoor A., Hoag, Stephen W., Polli, James, Raju, G. K., Woodcock, Janet
Julkaistu 2014

A Bioequivalence Approach for Generic Narrow Therapeutic Index Drugs: Evaluation of the Reference-Scaled Approach and Variability Comparison Criterion

Tekijä Jiang, Wenlei, Makhlouf, Fairouz, Schuirmann, Donald J., Zhang, Xinyuan, Zheng, Nan, Conner, Dale, Yu, Lawrence X., Lionberger, Robert
Julkaisussa AAPS J (2015)

Erratum to: A Bioequivalence Approach for Generic Narrow Therapeutic Index Drugs: Evaluation of the Reference-Scaled Approach and Variability Comparison Criterion

Tekijä Jiang, Wenlei, Makhlouf, Fairouz, Schuirmann, Donald J., Zhang, Xinyuan, Zheng, Nan, Conner, Dale, Yu, Lawrence X., Lionberger, Robert
Julkaisussa AAPS J (2015)

Scientific Considerations for Generic Synthetic Salmon Calcitonin Nasal Spray Products

Tekijä Lee, Sau L., Yu, Lawrence X., Cai, Bing, Johnsons, Gibbes R., Rosenberg, Amy S., Cherney, Barry W., Guo, Wei, Raw, Andre S.
Julkaistu 2010